NCT00547092已完成4 期
A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Preference Assessment measured by the Treatment Preference Question
研究概览
简要总结
To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •History of erection problems
- •Never taken treatments known as PDE5 inhibitors for erection issues
- •Abstain from using any other erection treatments during the study
- •Anticipate a monogamous female sexual relationship
- •Must be able to make required sexual intercourse attempts
排除标准
- •History of other primary sexual disorder
- •Treatment with nitrates
- •Have a penile implant or clinically significant penile deformity
- •History of certain heart problems
- •Do not meet certain lab value reference ranges
研究组 & 干预措施
1
Active Comparator
tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.
干预措施: tadalafil (Drug)
2
Active Comparator
sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.
干预措施: sildenafil (Drug)
结局指标
主要结局
Preference Assessment measured by the Treatment Preference Question
时间窗: 26 weeks
次要结局
- Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.(0, 12, and 26 weeks)
- Assess sexual encounters attributes measured by the PAIRS.(0, 12, and 26 weeks)
- Measure adverse events through the Side Effect Question.(12 and 26 weeks)
研究者
研究点 (1)
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